FDA Inspection 1074079 — Lyophilization Services Of New England, Inc.
The FDA completed an inspection of Lyophilization Services Of New England, Inc. on Dec 7, 2018 in Bedford, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 7, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bedford, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |